EFFICACY OF QUST SHIREEN (Saussurea lappa) ON SECONDARY AMENORRHEA DUE TO HYPOTHYROIDISM (EHTEBAS E TAMS BA SABAB QILLAT-E-DARQIYYAT)”RANDOMISED PLACEBO CONTROLLED STUDY.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To restore the menstrual cycle and to control the symptoms of hypothyroidism
研究概览
简要总结
Title of the study:
Efficacy of qust shireen (saussurea lappa) on secondary amenorrhea due to hypothyroidism- randomised placebo controlled study.
Aims of the study:
1.To prove the efficacy of Qust Shireen in the management of Secondary amenorrhea due to Hypothyroidism.
2.The primary goal of the Study is to restore the menstrual cycle.
Inclusion criteria:
Hypothyroidism diagnosed on basis of Zulewski scoring, USG whole abdomen and pelvis and Thyroid profile. Women within age of 15-40 years. Both married and unmarried. Both nulliparous and multiparous.
Exclusion criteria:
1.Patient with Severe Anaemia less than 8 gms
2.Use of hormonal therapy such as Oral contraceptives in the previous 3 months.
3.Thyroid dysfunction due to other causes such as Grave’s disease.
4.Patient with active or history of TB or Asthma.
5.Pregnancy
6.Lactation
Intervention:
Group A: Qust shireen (Saussurea lappa)
Group B: Corn Starch
Duration of treatment: 3months
Patients of Group A will be given Indian Costus powder 3gms per day in the form of capsule in two divided doses (1.5 g BD) for 15 days for three consecutive cycles accordingly.
Patients in Group B will given 3gms of placebo per day in the form of capsule in two divided doses for 15 days for 3 consecutive cycles (accordingly)
Outcomes:
-
Primary outcome: To restore the menstrual cycle and to control the symptoms of hypothyroidism.
-
Secondary outcome: Zulewski scoring, Arbitary scaling for menstrual cycle pattern.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Hypothyroidism diagnosed on basis of Zulewski scoring, USG whole abdomen and pelvis and Thyroid profile.
- •Women within age of 15-40 years.
- •Both married and unmarried.
- •Both nulliparous and multiparous.
排除标准
- •1.Patient with Severe Anaemia less than 8 gms 2.Use of hormonal therapy such as Oral contraceptives in the previous 3 months.
- •3.Thyroid dysfunction due to other causes such as Grave’s disease.
- •4.Patient with active or history of TB or Asthma.
- •5.Pregnancy 6.Lactation.
结局指标
主要结局
To restore the menstrual cycle and to control the symptoms of hypothyroidism
时间窗: 0th day to 90th day
次要结局
- Zulewski scoring, Arbitary scaling for menstrual cycle pattern(Assessments will be done at baseline (Day 0),Day 30, Day 60 and Day 90.)
研究者
Dr Farheen Taqi
Government Nizamia Tibbi college and General hospital
